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Search / Trial NCT00962156

Scandinavian Starch for Severe Sepsis/Septic Shock Trial

Launched by ANDERS PERNER · Aug 18, 2009

Trial Information

Current as of April 29, 2025

Completed

Keywords

Sepsis Shock Fluid Therapy Plasma Expanders

ClinConnect Summary

Fluid is the mainstay treatment in sepsis resuscitation, but the effects of different crystalloid and colloid solutions on outcome remain unknown.

Previously, a high molecular weight hydroxyethyl starch, HES 200, was used, but this was found to cause acute kidney failure in patients with severe sepsis. As kidney failure is an independent risk factor for death in these patients, HES 200 is not used anymore. In stead a lower molecular weight starch, HES 130, has been developed. Presently, this is the preferred colloid in Scandinavian intensive care units (ICU), but the effects of HES 130 in ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All adult patients who
  • Undergo resuscitation in the ICU
  • AND fulfillment within the previous 24 hours of the criteria for severe sepsis (SCCM/ACCP)
  • AND consent is obtainable either from the patient or by proxy (physician and/or next of kin)
  • Exclusion Criteria:
  • The following patients will not be evaluated for inclusion:
  • Age \< 18 years old
  • Previously randomised in the 6S trial
  • Allergy towards hydroxyethyl starch or malic acid
  • Treatment with \> 1000 ml's of any synthetic colloid within the last 24 hours prior to randomisation
  • Any form of renal replacement therapy
  • Acute burn injury \> 10% body surface area
  • Severe hyperkalaemia, p-K \> 6 mM
  • Liver or kidney transplantation during current hospital admission
  • Intracranial bleeding within current hospitalisation
  • Enrollment into another ICU trial of drugs with potential action on circulation, renal function or coagulation
  • Withdrawal of active therapy

About Anders Perner

Anders Perner is a distinguished clinical trial sponsor renowned for his commitment to advancing medical research and improving patient outcomes. With a robust background in critical care medicine, he leads initiatives that focus on innovative trial designs and the integration of cutting-edge technologies in clinical studies. His collaborative approach fosters partnerships between academic institutions and industry stakeholders, ensuring rigorous scientific methodologies are applied to address pressing healthcare challenges. Under his guidance, clinical trials are conducted with an emphasis on ethical standards, patient safety, and the generation of high-quality evidence to inform clinical practice.

Locations

Copenhagen, , Denmark

Odense, , Denmark

Stavanger, , Norway

Copenhagen, , Denmark

Copenhagen, , Denmark

Copenhagen, , Denmark

Bergen, , Norway

Esbjerg, , Denmark

Herning, , Denmark

Vejle, , Denmark

Copenhagen, , Denmark

Copenhagen, , Denmark

Hillerød, , Denmark

Hjørring, , Denmark

Holbæk, , Denmark

Holstebro, , Denmark

Køge, , Denmark

Næstved, , Denmark

Slagelse, , Denmark

Sønderborg, , Denmark

Helsinki, , Finland

Kuopio, , Finland

Tampere, , Finland

Reykjavik, , Iceland

Tromsø, , Norway

Trondheim, , Norway

Patients applied

0 patients applied

Trial Officials

Anders Perner, MD, PhD

Principal Investigator

ICU, Rigshospitalet, University of Copenhagen

Nicolai Haase, MD

Study Director

Rigshospitalet, Denmark

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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